K232842 is an FDA 510(k) clearance for the Balloon Inflation System. This device is classified as a Cement, Bone, Vertebroplasty (Class II - Special Controls, product code NDN).
Submitted by Ningbo Hicren Biotechnology Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on February 29, 2024, 168 days after receiving the submission on September 14, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3027.
| 510(k) Number | K232842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 2023 |
| Decision Date | February 29, 2024 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | NDN - Cement, Bone, Vertebroplasty |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3027 |